HeartWare International Inc said it received a warning letter from the U.S. Food and Drug Administration following an inspection of its manufacturing plant in Florida in January.
The FDA has not restricted the use of HeartWare devices, the company said in a statement.
HeartWare makes miniature implantable heart pumps to treat patients suffering from advanced heart failure.
(Reporting by Natalie Grover in Bangalore; Editing by Saumyadeb Chakrabarty)
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